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Abstract:

The invention encompasses compositions and methods for maintaining or
promoting a healthy body composition in a companion animal, which
comprises feeding the animal an edible composition comprising one or more
pyruvate in an amount effective to maintain or promote the healthy body
composition, wherein maintaining or promoting the healthy body
composition comprises controlling the animal's weight, for example, loss
of weight or body fat, or increased percentage of lean muscle mass.

Claims:

1. A method for maintaining or promoting a healthy body composition in a
companion animal, which comprises feeding the animal an edible
composition comprising one or more pyruvate in an amount effective to
maintain or promote the healthy body composition.

3. The method of claim 1 or claim 2 wherein the animal is overweight,
obese, or has a tendency to be overweight or obese.

4. The method of any preceding claim, wherein the one or more pyruvate is
present in the composition in an amount of up to about 20% by weight of
the composition.

5. The method of any preceding claim, wherein the one or more pyruvate is
present in the composition in an amount of about 0.1 to 10% by weight of
the composition.

6. The method of any preceding claim, wherein the one or more pyruvate is
present in the composition in an amount of about 5% by weight of the
composition.

7. The method of any preceding claim, wherein the composition further
comprises a component selected from the group consisting of protein, fat,
carbohydrate, fiber, and combinations thereof.

8. The method of any preceding claim, wherein the composition is a food,
a nutritional diet, a supplement, an animal treat, or a toy.

9. The method of any preceding claim, wherein the companion animal is a
dog.

10. The method of any one of claims 1-8, wherein the companion animal is
a cat.

Description:

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent
Application No. 61/290,780 filed on 29 Dec. 2009, which is incorporated
herein by reference.

BACKGROUND OF THE INVENTION

[0002] An important indicator of animal health is the body composition of
the animal. An unhealthy diet and/or an unhealthy lifestyle can result in
the animal having an unhealthy proportion of body fat, particularly in
relation to lean muscle in the body. It is thought that a body fat amount
in excess of 30% by weight indicates that the animal is unhealthy,
particularly if the amount of body fat is in excess of 35% by weight.

[0003] Animals, particularly companion animals (e.g., dogs and cats), may
weigh more than their ideal body weight. Having an excess of adipose
tissue, these animals may be clinically diagnosed as, e.g., "fat",
"overweight", or "obese" and, as such, are more likely to suffer from
associated physical disorders such as arthritis, heart disease,
respiratory disease, diabetes, bladder cancer, hypothyroidism, joint
disease and/or pancreatitis.

[0004] Attempts to prevent or reduce the amount of excess adipose tissue
on companion animals typically include dietary restriction and exercise.
Indeed, many "low" or "reduced" calorie foods for overweight companion
animals have been developed and are commercially available for the
control of calorie intake, prevention of weight gain, or for the
promotion of weight loss. One strategy in weight loss involves high
protein diets with high protein to calorie ratios in order to reduce the
amount of body fat in humans. A similar approach has been used in
companion animal products. High protein diets have proven to be effective
in weight loss in cats; however high protein foods have had mixed results
when applied to canine weight management programs. Treatment strategies
also include increasing the fiber and/or protein content while reducing
the fat in the food. Depending on the fiber source, the fiber can induce
satiety via gut distention or through feedback mechanisms (e.g., GLP-1).
Fiber can be effective in reducing the digestibility of food resulting in
a lower availability of high calorie nutrient components (i.e., fat and
carbohydrates).

[0005] Generally, companion animals such as canines and felines weighing
more than 15% of their ideal body weight are considered overweight or
obese. Overweight animals generally have an excess of body adipose
tissue. The most common cause of an animal being overweight is an over
consumption of food that results in an excess intake of calories.
However, there are other factors that can increase an animal's chances
for being overweight, e.g., lifestyle, health, eating habits, breed,
spaying, and neutering. Also, the incidence of animals becoming
overweight generally increases with age due to a general decrease in
metabolic rate and in physical activity. Surveys estimate that 25% of
canines in the United States that visit veterinary clinics are fat to the
point of being obese.

[0006] Losing weight or maintaining weight, particularly for a companion
animal, is difficult. It is necessary to modulate the caloric intake of
the animal. Modulating the amount of adipose tissue on a companion
animal, including preventing an animal from becoming overweight or
treating a fat animal to reduce the amount of adipose tissue on the
animal, is also difficult. An effective way to prevent an animal from
becoming fat or to reduce the amount of fat on an animal is with dietary
restriction and exercise. However, it is often difficult to ensure
compliance with diet and exercise programs.

[0007] Given the problems with current methods for losing weight or
maintaining weight, there is a continuing need for new methods and
compositions useful for maintaining or promoting a healthy body
composition, wherein maintaining or promoting a healthy body composition
comprises controlling the animal's weight, for example, loss of weight or
body fat, or increased percentage of lean muscle mass, in a companion
animal and, in particular, for food compositions effective in these
conditions.

SUMMARY OF THE INVENTION

[0008] Accordingly, the inventors have developed edible compositions,
including nutritionally complete dietary compositions for a companion
animal, which include pyruvate to confer clinically beneficial properties
with regard to maintaining or promoting a healthy body composition to
such companion animal, wherein maintaining or promoting a healthy body
composition may comprise controlling the animal's weight.

[0009] Another embodiment encompasses methods for maintaining or promoting
a healthy body composition, wherein maintaining or promoting a healthy
body composition comprises controlling the animal's weight, for example,
loss of weight or body fat, or increased percentage of lean muscle mass
in a companion animal, which includes feeding the animal an edible
composition including one or more pyruvate in an amount effective to
maintain or promote the healthy body composition.

DETAILED DESCRIPTION OF THE INVENTION

[0010] As used throughout, ranges are used as a shorthand for describing
each and every value that is within the range. Any value within the range
can be selected as the terminus of the range. In addition, all references
cited herein are hereby incorporated by reference in their entireties. In
the event of a conflict in a definition in the present disclosure and
that of a cited reference, the present disclosure controls.

[0011] Unless otherwise specified, all percentages and amounts expressed
herein and elsewhere in the specification should be understood to refer
to percentages by weight.

[0012] The invention generally encompasses companion animal edible
compositions including one or more pyruvate in an amount effective to
treat or prevent a disorder in the companion animal.

[0013] The invention additionally encompasses methods for the prevention,
amelioration of symptoms of, or treatment of certain conditions,
disorders and diseases in companion animals, for example, for promoting
or maintaining healthy body compositions.

[0014] In one embodiment, maintaining or promoting a healthy body
composition comprises controlling the animal's weight.

[0015] In another embodiment, the animal is overweight, obese, or has a
tendency to be overweight or obese.

[0016] In another embodiment, the companion animal is a dog or cat.

[0017] In another embodiment, the pyruvate is present in an amount of up
to about 20% by weight of the composition.

[0018] In another embodiment, the pyruvate is present in an amount of
about 0.1% by weight to about 10% by weight of the composition

[0019] In another embodiment, the pyruvate is in an amount of about 5% by
weight of the composition.

[0020] In another embodiment, the pyruvate is in an amount of about 1% by
weight of the composition.

[0021] In another embodiment, the pyruvate is in an amount of about 0.7%
by weight of the composition.

[0022] In another embodiment, the composition further includes one or more
proteins, fats, carbohydrates, fibers, and combinations thereof.

[0023] In another embodiment, the composition is a food, a nutritional
diet, a supplement, an animal treat, or a toy.

[0024] In another embodiment, the edible composition is in the form of a
moist food, dry food, supplement or treat.

[0025] Another embodiment of the invention encompasses methods for
maintaining or promoting a healthy body composition in a companion
animal, which includes feeding the animal an edible composition of the
invention, which includes one or more pyruvate in an amount effective to
maintain or promote the healthy body composition in such companion
animal, wherein maintaining or promoting a healthy body composition
comprises controlling the animal's weight.

[0026] It is contemplated that the invention described herein is not
limited to the particular methodology, protocols, ingredients and
reagents described as these may vary. It is also to be understood that
the terminology used herein is for the purpose of describing particular
embodiments only, and is not intended to limit the scope of the present
invention in any way.

[0027] Unless defined otherwise, all technical and scientific terms used
herein have the same meanings as commonly understood by one of ordinary
skill in the art to which this invention belongs. Although any methods
and materials similar or equivalent to those described herein can be used
in the practice or testing of the present invention, the preferred
methods, devices and materials are now described. All publications
mentioned herein are incorporated by reference for the purpose of
describing and disclosing the materials and methodologies that are
reported in the publication, which might be used in connection with the
invention.

[0028] As used herein and in the appended claims, the singular forms, and
"the" include plural reference unless the context clearly dictates
otherwise.

[0029] The term "antioxidant" means a substance that is capable of
reacting with free radicals and neutralizing them. Illustrative examples
of such substances include beta-carotene, selenium, coenzyme Q10
(ubiquinone), luetin, tocotrienols, soy isoflavones,
S-adenosylmethionine, glutathione, taurine, N-acetylcysteine, vitamin E,
vitamin C, lipoic acid and L-carnitine. Examples of foods containing
useful levels of one or more antioxidants include but are not limited to,
ginkgo bilboa, green tea, broccoli, citrus pulp, grape pomace, tomato
pomace, carrot spinach, and a wide variety of fruit meals and vegetable
meals. It will be understood by one of skill in the art that while units
of antioxidants may be provided herein as "ppm", appropriate amounts of
antioxidants may also be provided as "IU/kg" where appropriate and
customary for a given antioxidant such as, e.g., Vitamin E.

[0030] The term "carbohydrate" as used herein includes polysaccharides
(e.g., starches and dextrins) and sugars (e.g., sucrose, lactose,
maltose, glucose, and fructose) that are metabolized for energy when
hydrolyzed. Examples of carbohydrates suitable for inclusion in the
compositions disclosed herein include but are not limited to, corn, grain
sorghum, wheat, barley, and rice.

[0031] The term "cat" includes those cats which are companion animals
known as domestic cats or house cats.

[0032] The term "companion animal" used in the present invention includes
any non-human animal suitable for being kept as a pet by humans including
a dog and a cat. All aspects of the present invention are preferably for
the treatment of cats and/or dogs.

[0033] As used herein the term "compositions of the invention" refers to
animal dietary food compositions including pyruvate. The compositions of
the invention include pyruvate in an amount of about 0.1%, about 0.2%,
about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%,
about 0.9%, about 1%, about 1.5%, about 2%, about 3%, about 4%, about 5%,
about 6%, about 7%, about 8%, about 9%, about 10%, about 15%, or about
20% by weight. The compositions of the invention may maintain or promote
a healthy body composition in a companion animal fed such compositions,
wherein maintaining or promoting the healthy body composition comprises
controlling the animal's weight, for example, loss of weight or body fat,
or increased percentage of lean muscle mass

[0034] The term "dog" includes those dogs which are companion animals such
as Canis familiaris, working dogs and the like. The term dog is
synonymous with the term canine.

[0035] As used herein, "an amount effective", "an effective amount", and
like terms refer to that amount of a compound, material or composition as
described herein that may be effective to achieve a particular biological
result. Such effective activity may be achieved, for example, by
administration of compositions of the present invention to an animal. An
effective amount may be based on several factors, including an animal's
ideal weight, the metabolizable energy of the composition, and frequency
of feeding the animal compositions of the present invention, e.g., once,
twice, or three times daily, and other compositions fed to the animal.

[0036] A "food" is a nutritionally complete diet for the intended
recipient animal (e.g., domestic cat or domestic dog).

[0037] As used herein, an "ingredient" refers to any component of a
composition.

[0038] As used herein, the terms "pyruvate" includes, but is not limited
to, for example, pyruvic acid and salts and esters of pyruvic acid,
including but not limited to: calcium pyruvate, sodium pyruvate, lithium
pyruvate, potassium pyruvate, magnesium pyruvate, zinc pyruvate,
manganese pyruvate and combinations thereof. The term "pyruvate" also
includes certain pyruvate precursor molecules in the form of pyruvamides
or pyruvyl-amino acids. The term pyruvyl-amino acids includes,
pyruvyl-glycine, pyruvyl-glutamine, pyruvyl-lysine, pyruvyl-valine,
pyruvyl-isoleucine, pyruvyl-phenylalanine, pyruvyl-proline and their
amides, esters, salts and mixtures thereof. The term "pyruvate" also
include derivatives of pyruvic acid such as ethyl pyruvate, propyl
pyruvate, butyl pyruvate, carbmethoxymethyl pyruvate, carbethoxymethyl
pyruvate, acetoxymethyl pyruvate, carbmethoxyethyl pyruvate,
carbethoxylethyl pyruvate, methoxymethyl pyruvate and ethoxymethyl
pyruvate. The term "pyruvate" also includes mixtures of any of the
foregoing substances. In certain preferred embodiments, the pyruvate is
calcium pyruvate.

[0039] The terms "sample" and "specimen" mean any animal tissue or fluid
containing, e.g., polynucleotides, polypeptides, antibodies, metabolites,
and the like, including cells and other tissue containing DNA and RNA.
Examples include: blood, cartilage, connective, epithelial, lymphoid,
muscle, nervous, sputum, and the like. A sample may be solid or liquid
and may be DNA, RNA, cDNA, bodily fluids such as blood or urine, cells,
cell preparations or soluble fractions or media aliquots thereof,
chromosomes, organelles, and the like.

[0040] As used herein, "soluble fiber" refers to dietary fiber that
attracts water during digestion and slows the rate of nutrient absorption
and is typically found in, e.g., oat bran, seeds, beans, and certain
fruits and vegetables such as beet pulp, guar gum, chicory root,
psyllium, pectin, blueberry, cranberry, squash, apples, oats, beans,
citrus, barley and peas. As used herein, the term encompasses any source
of soluble fiber suitable for the compositions disclosed herein as would
be evident to one of skill in the art.

[0041] As used herein, the term "supplement(s)" include but are not
limited to, a feed used with another feed to improve nutritive balance or
performance of the total. Supplements include but are not limited to,
compositions that are fed undiluted as a supplement to other feeds,
offered free choice with other parts of an animal's ration that are
separately available, or diluted and mixed with an animal's regular feed
to produce a complete feed. The AAFCO guidelines, for example, contain a
discussion relating to supplements in the Official Publication of The
Association of American Feed Control Officials, Inc. (AAFCO), Atlanta,
Ga., 2005, or the National Research Council's Nutrient Requirements of
Dogs and Cats, The National Academy Press, Washington, D.C., 2006.

[0042] Supplements may be in various foams including, for example,
powders, liquids, syrups, pills, encapsulated compositions, and the like.

[0043] The term "nutrient" refers to a substance that provides
nourishment. In some cases an ingredient may comprise more than one
"nutrient," for example, a composition may comprise fish oil as an
ingredient, the oil itself comprising important nutrients such as
eicosapentaenoic acid and docosahexaenoic acid. The distinction in these
terms is familiar to one of skill in the art.

[0044] As contemplated herein, the compositions of the present invention
are meant to encompass nutritionally complete and balanced animal food
compositions that additionally comprise pyruvate. A "nutritionally
complete diet" is a diet that includes sufficient nutrients for
maintenance of normal health of a healthy animal on the diet.

[0045] Nutritionally complete and balanced pet food compositions are
familiar to one of skill in the art. For example, substances such as
nutrients and ingredients suitable for nutritionally complete and
balanced animal feed compositions, and recommended amounts thereof, may
be found for example, in the Official Publication of The Association of
American Feed Control Officials, Inc. (AAFCO), Atlanta, Ga., 2005, or the
National Research Council's Nutrient Requirements of Dogs and Cats, The
National Academy Press, Washington, D.C., 2006.

[0046] For example, a nutritionally complete and balanced pet food
composition of the present invention may comprise: about 0 to about 90%,
preferably about 5% to 60%, by weight of carbohydrates; about 5% to about
70%, preferably about 10% to about 60%, by weight of protein; about 2% to
about 50%, preferably about 5% to about 40%, by weight of fat; about 0.1%
to about 40%, preferably about 1% to about 11%, by weight of total
dietary fiber; about 0 to about 15%, preferably about 2% to about 8%, by
weight of vitamins and minerals, antioxidants, and other nutrients which
support the nutritional needs of the animal; and about 0.1% to about 20%
by weight of pyruvate.

[0047] One embodiment of the invention encompasses edible compositions for
companion animals including one or more pyruvate.

[0048] Another embodiment encompasses methods for maintaining or promoting
a healthy body composition, wherein maintaining or promoting a healthy
body composition comprises controlling the animal's weight, for example,
loss of weight or body fat, or increased percentage of lean muscle mass
in a companion animal, which includes feeding the animal an edible
composition including one or more pyruvate in an amount effective to
maintain or promote the healthy body composition.

[0049] The compositions of the invention may include pyruvate in an amount
effective to maintain or promote a healthy body composition, wherein
maintaining or promoting a healthy body composition comprises controlling
the animal's weight, for example, loss of weight or body fat, or
increased percentage of lean muscle mass, in a companion animal.

[0050] Generally, the amount effective in the composition includes one or
more pyruvate in an amount of up to about 20% by weight, up to about 18%
by weight, up to about 16% by weight, up to about 14% by weight, up to
about 12% by weight, up to about 10% by weight, up to about 9% by weight,
up to about 8% by weight, up to about 7% by weight, up to about 6% by
weight, up to about 5% by weight, up to about 4% by weight, up to about
3% by weight, up to about 2% by weight of the composition, or up to about
1% by weight. In certain embodiments, the one or more pyruvate is present
in an amount of 0.5 to 1.0% by weight of the composition, and in other
embodiments the one or more pyruvate is present in an amount of
approximately 0.7% by weight of the composition.

[0051] The invention generally encompasses pet food compositions for a
companion animal comprising an amount of protein, an amount of fat, an
amount of carbohydrate, an amount of fiber and an effective amount of one
or more pyruvate to maintain or promote a healthy body composition in a
companion animal.

[0052] In certain embodiments, the effective amount of pyruvate is at
least 0.1% by weight pyruvate. In other embodiments of the invention one
or more pyruvate is present in a range of about 0.1% to about 20% by
weight on a dry matter basis. In preferred embodiments the pyruvate is
present in an amount of about 0.7% by weight on a dry matter basis.

[0053] In certain embodiments, the companion animal is a dog.

[0054] In certain embodiments, the companion animal is a cat.

[0055] In various embodiments, the companion animals of the invention are
the domestic cat (Felis domesticus) or the domestic dog (Canis
domesticus). Other companion animals include, fish, bird and horse.

[0056] In another embodiment, the animal is overweight, obese, or has a
tendency to be overweight or obese.

[0057] In certain embodiments, the dietary food composition can be
administered to an overweight or obese animal or to an animal that has a
tendency to be overweight or obese.

[0058] The edible compositions, in addition to one or more pyruvate, may
also include at least one component suitable for consumption by a
companion animal including, but not limited to, fats, carbohydrates,
proteins, fibers, nutritional balancing agents such as vitamins,
minerals, and trace elements, and mixtures thereof. One of ordinary skill
in the art can select the amount and type of food ingredients for a
typical food based upon the dietary requirements of the animal, for
example, the animal's species, age, size, weight, health, and function.

[0059] A "nutritionally complete diet" is a diet that includes sufficient
nutrients for maintenance of normal health of a healthy animal on the
diet. The methods of this invention utilize compositions that are not
intended to be restricted by any specific listing of proteinaceous or fat
ingredients or product form. The compositions can be prepared in, for
example, a dry, canned, wet, or intermediate moisture form using
conventional pet food processes.

[0060] The food composition can include up to about 100% of any particular
food ingredient or can include a mixture of food ingredients in various
proportions. In certain embodiments, the food composition includes a
combination of food ingredients in amounts of about 0 wt. % to 50 wt. %
fat, 0 wt. % to 75 wt. % carbohydrate, 0 wt. % to 95 wt. % protein, 0 wt.
% to 40 wt. % dietary fiber, and 0 wt. % to 15 wt. % of one or more
nutritional balancing agents.

[0061] In one illustrative embodiment, the composition may, for example,
in addition to one or more pyruvate also include at least one of the
following:

[0062] (a) about 0% to about 75% carbohydrate;

[0063] (b) about 2% to about 50% fat;

[0064] (c) about 0% to about 40% dietary fiber, and

[0065] (d) about 0% to about 15% of one or more nutritional balancing
agents.

[0066] In certain embodiments, the fat and carbohydrate food ingredient is
obtained from a variety of sources such as animal fat, fish oil,
vegetable oil, meat, meat by-products, grains, other animal or plant
sources, and mixtures thereof. Grains include wheat, corn, barley, and
rice. In certain embodiments, protein may be supplied by any of a variety
of sources known by those skilled in the art, including plant sources,
animal sources, or both. Animal sources include, for example, meat, meat
by-products, seafood, dairy, eggs, etc. Meats include, for example, the
flesh of poultry, fish, and mammals (e.g., cattle, pigs, sheep, goats,
and the like). Meat by-products include, for example, lungs, kidneys,
brain, livers, and stomachs and intestines (freed of all or essentially
all their contents). The protein can be intact, almost completely
hydrolyzed, or partially hydrolyzed. Protein content of foods may be
determined by any number of methods known by those of skill in the art,
for example, as published by the Association of Official Analytical
Chemists in Official Methods of Analysis ("OMA"). The amount of "crude
protein" in a composition disclosed herein may be determined based on the
amount of nitrogen in the composition according to methods familiar to
one of skill in the art.

[0067] The compositions of the present invention may also include amino
acids in amounts required to avoid deficiency and maintain health. These
amounts and methods of measurement are known by those skilled in the art.
For example, AAFCO provides recommended amounts of such ingredients for
dogs and cats. Amino acids in the present compositions may be supplied by
any number of sources, including crude protein, or addition of free amino
acids to the composition.

[0068] Fat can be supplied by any of a variety of sources known by those
skilled in the art, including meat, meat by-products, fish oil, and
plants. Plant fat sources include wheat, flaxseed, rye, barley, rice,
sorghum, corn, oats, millet, wheat germ, corn germ, soybeans, peanuts,
and cottonseed, as well as oils derived from these and other plant fat
sources. Fat content of foods may be determined by any number of methods
known by those of skill in the art.

[0069] Carbohydrate may be supplied by any of a variety of sources known
by those skilled in the art, including oat fiber, cellulose, peanut
hulls, beet pulp, parboiled rice, corn starch, corn gluten meal, and any
combination of those sources. Grains supplying carbohydrate include, but
are not limited to, wheat, corn, barley, and rice. Carbohydrate content
of foods may be determined by any number of methods known by those of
skill in the art. Generally, carbohydrate percentage may be calculated as
nitrogen free extract ("NFE"), which may be calculated as follows:
NFE=100%-moisture %-protein %-fat %-ash %-crude fiber %.

[0070] As used herein, "fiber blend" includes a combination of soluble and
insoluble fiber at a level that is between 1-5% total dietary fiber on a
dry matter basis. The sources of the fiber can be combinations of
cellulose, hemicelluloses, resistant starches, or oligosaccharides such
as galactooligosaccharides, xylooligosaccharides, or
fructooligosaccharides.

[0071] Dietary fiber refers to components of a plant that are resistant to
digestion by an animal's digestive enzymes. Dietary fiber components of
foods may be determined by any number of methods known by those of skill
in the art, such as those published by the OMA. Dietary fiber includes
soluble and insoluble fibers.

[0072] Soluble fiber are resistant to digestion and absorption in the
small intestine and undergo complete or partial fermentation in the large
intestine, e.g., beet pulp, guar gum, chicory root, psyllium, pectin,
blueberry, cranberry, squash, apples, oats, beans, citrus, barley, or
peas. Insoluble fiber may be supplied by any of a variety of sources,
including cellulose, whole wheat products, wheat oat, corn bran, flax
seed, grapes, celery, green beans, cauliflower, potato skins, fruit
skins, vegetable skins, peanut hulls, and soy fiber. Soluble and
insoluble fiber content of foods may be determined by any number of
methods known by those of skill in the art. Crude fiber includes
indigestible components contained in cell walls and cell contents of
plants such as grains, e.g., hulls of grains such as rice, corn, and
beans. Crude fiber content of foods may be determined by any number of
methods known by those of skill in the art.

[0073] In certain embodiments, the fiber food ingredient is obtained from
a variety of sources such as vegetable fiber sources, for example,
cellulose, beet pulp, peanut hulls, and soy fiber.

[0074] Metabolizable energy (ME) of a diet is the energy available to an
animal upon consumption of the diet after subtracting the energy excreted
in feces, urine, and combustible gases. Metabolizable energy values may
be determined by methods known by those skilled in the art, such as
detailed in the Official Publication of The Association of American Feed
Control Officials, Inc. or the National Research Council's Nutrient
Requirements of Dogs and Cats, The National Academy Press, Washington,
D.C., 2006.

[0075] "Ash" consists of compounds that are not organic or water,
generally produced by combustion of biological materials. Ash may be
determined by any number of methods known by those of skill in the art.

[0076] Carnitine, or L-carnitine, is a vitamin-like compound synthesized
in the body from lysine and methionine. Carnitine may be naturally
present in ingredients of the present invention, or carnitine may be
added to the compositions.

[0077] The compositions of the present invention also may contain one or
more minerals and/or trace elements, e.g., calcium, phosphorus, sodium,
potassium, magnesium, manganese, copper, zinc, or iron salts. One
particular trace element is manganese. Manganese is essential to a host
of enzymes as a cofactor, which may regulate the metabolism of foods,
including proteins, fats, and carbohydrates. Such enzymes may include
oxidoreductases, transferases, hydrolases, lyases, isomerases, ligases,
lectins, and integrins. Manganese also affects bone development and
neurological function. Manganese may be naturally present in the
components of the compositions, or it may be added to compositions.
Methods of measuring manganese content in a composition are well known to
those of skill in the art.

[0078] The compositions of the present invention may also include vitamins
and minerals in amounts required to avoid deficiency and maintain health.
These amounts and methods of measurement are known by those skilled in
the art. For example, AAFCO provides recommended amounts of such
ingredients for dogs and cats. As contemplated herein, useful vitamins
may include, but are not limited to, vitamin A, vitamin B1, vitamin
B2, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin
E, vitamin H (biotin), vitamin K, folic acid, inositol, niacin, and
pantothenic acid.

[0079] In certain embodiments, the nutritional balancing agents are
obtained from a variety of sources known to skilled artisans, for
example, vitamin and mineral supplements and food ingredients. Vitamins
and minerals can be included in amounts required to avoid deficiency and
maintain health. These amounts are readily available in the art. The
Association of American Feed Control Officials, Inc. provides recommended
amounts of such nutrients for dogs and cats. Vitamins generally useful as
food additives include vitamin A, vitamin B1, vitamin B2, vitamin B6,
vitamin B12, vitamin D, biotin, vitamin K, folic acid, inositol, niacin,
and pantothenic acid. Minerals and trace elements useful as food
additives include calcium, phosphorus, sodium, potassium, magnesium,
copper, zinc, chloride, iron, selenium, iodine, and iron.

[0080] In certain embodiments, the food compositions may contain
additional ingredients such as fillers, palatability enhancers, binding
agents, flavors, stabilizers, emulsifiers, sweeteners, colorants,
buffers, salts, coatings, and the like known to skilled artisans.
Stabilizers include substances that tend to increase the shelf life of
the composition such as preservatives, synergists and sequestrants,
packaging gases, stabilizers, emulsifiers, thickeners, gelling agents,
and humectants. Examples of emulsifiers and/or thickening agents include
gelatin, cellulose ethers, starch, starch esters, starch ethers, and
modified starches. Specific amounts for each composition component, food
ingredient, and other ingredients will depend on a variety of factors
such as the particular components and ingredients included in the
composition; the species of animal; the animal's age, body weight,
general health, sex, and diet; the animal's consumption rate; the type of
disease or condition being treated; and the like. Therefore, the
component and ingredient amounts may vary widely and may deviate from the
preferred proportions described herein.

[0081] The invention encompasses pet food compositions or supplements
wherein one or more pyruvate is present in an effective amount to
prevent, ameliorate one or more symptoms of, or treat, a condition in a
companion animal. The effective amount of one or more pyruvate may vary
depending on such factors as the patient being treated, the particular
mode of administration, the activity of the particular active ingredients
employed, the age, bodyweight, general health, sex and diet of the
patient, time of administration, rate of excretion, the particular
combination of ingredients employed, the total content of the main
ingredient of the nutritional supplement or nutritionally complete diet,
and the severity of the illness or symptom. It is within the skill of the
person of ordinary skill in the art to account for these factors.

[0082] The food composition may further contain other ingredients such as
corn, poultry meal, grease, palatability enhancers, potassium chloride,
iodized salt, calcium carbonate, choline chloride, mineral premix,
preservative, vitamin premix. The food may contain protein. The protein
may be animal protein. Animal protein may be part of the total protein.
Animal protein may be 50%, 70%, 80%, 90%, 95%, 99% or 100% of the total
protein. The food may contain antioxidants, such as vitamin E.
Antioxidant may be present in between about 0.0001 U/g and 3.0 U/g food,
such as, e.g., 0.18 U/g. The food may contain eicosapentaenoic acid (EPA)
at between 1% by weight and 5% weight. Fatty acids may also be included
such as n-3 and n-6 fatty acids. Fatty acids may be present in about
0.05% to 5% by weight. n-3 fatty acids may be present in about 0.0001% to
2%. n-6 fatty acids may be present in about 0.5% to 5% by weight. The
food may contain fiber, such as crude fiber. Fiber may be present in
between 0.001% and 10% by weight.

[0083] The effective amount of the nutritional supplement will vary
depending on such factors as the patient being treated, the particular
mode of administration, the activity of the particular active ingredients
employed, the age, body weight, general health, sex and diet of the
patient, time of administration, rate of excretion, the particular
combination of ingredients employed, the total content of the main
ingredient of the nutritional supplement, and the severity of the illness
or symptom. It is within the skill of the person of ordinary skill in the
art to account for these factors.

[0084] The pyruvate-containing dietary foods or supplements of the present
invention may be formulated using a safe and effective amount of one or
more pyruvate as discussed herein to provide one or more of the
beneficial effects of the invention described herein, and one or more of
the optional ingredients which may be obtained from slippery elm or green
tea, as well as one or more of the additional optional ingredients
described below. The nutritional supplement of the present invention may
also be formulated with a pharmaceutically acceptable carrier.

[0085] Other materials, which may optionally be included in the
nutritional supplement of the present invention include inositol, other
B-complex vitamins, and anti-inflammatories. Also, ingredients such as
sweeteners, flavorants, coloring agents, dyes, preservatives, emulsifying
agents, suspending agents, melting agents, excipients, and solvents or
diluents such as water, ethanol, propylene glycol, glycerin and various
combinations thereof, may be included in the pyruvate-containing foods or
supplements of the present invention.

[0086] The optional sweeteners, which may be used in the
pyruvate-containing foods or supplements of the present invention
include, but are not limited to, saccharin, aspartame, cyclamates,
acesulfame K, neohesperidin dihydrochalcone, other sweeteners, and
mixtures thereof, which may be added to the carrier in amounts
sufficiently low so as not to chemically interact with the main
ingredients of the nutritional supplement.

[0087] The optional flavorants which may be used in the
pyruvate-containing foods or supplements of the present invention
include, but are not limited to, peppermint, peppermint-menthol,
eucalyptol wintergreen, licorice, clove, cinnamon, spearmint, cherry,
lemon, orange lime, menthol and various combinations thereof.

[0088] Such additives are present in amounts that do not impair the
purpose and effect provided by the invention. Examples of additives
include, for example, substances with a stabilizing effect, processing
aids, substances that enhance palatability, coloring substances, and
substances that provide nutritional benefits.

[0090] Additives for coloring, palatability, and nutritional purposes
include, for example, colorants (e.g., iron oxide, such as the red,
yellow, or brown forms); sodium chloride, potassium citrate, potassium
chloride, and other edible salts; vitamins; minerals; and flavoring. Such
additives are known in the art. See, e.g., U.S. Pat. No. 3,202,514. See
also, U.S. Pat. No. 4,997,671. Flavorants include, for example, dairy
product flavorants (e.g., milk or cheese), meat flavorants (e.g., bacon,
liver, beef, poultry, or fish), oleoresin, pinacol, and the various
flavorants identified in the trade by a FEMA (Flavor Extract
Manufacturers Association) number. Flavorants help provide additional
palatability, and are known in the art. See, e.g., U.S. Pat. No.
4,997,672. See also, U.S. Pat. No. 5,004,624, U.S. Pat. No. 5,114,704,
U.S. Pat. No. 5,532,010, and U.S. Pat. No. 6,379,727. The concentration
of such additives in the composition typically may be up to about 5% by
weight. In some embodiments, the concentration of such additives
(particularly where such additives are primarily nutritional balancing
agents, such as vitamins and minerals) is from about 0% to about 2.0% by
weight. In some embodiments, the concentration of such additives (again,
particularly where such additives are primarily nutritional balancing
agents) is from about 0% to about 1.0% by weight.

[0091] The composition of the invention may include one or more additional
ingredients to prevent or treat one or more diseases or conditions. The
component in the diet, which accomplishes this, may be an antioxidant or
mixture thereof. An antioxidant is a material that quenches a free
radical. Examples of such materials include foods such as Ginkgo Biloba,
citrus pulp, grape pomace, tomato pomace, carrot and spinach, all
preferably dried as well as various other materials such as
beta-carotene, selenium, coenzyme Q10 (ubiquinone), lutein, tocotrienols,
soy isoflavones, S-adenosylmethionine, glutathione, taurine,
N-acetylcysteine, Vitamin E, Vitamin C, alpha-lipoic acid, l-carnitine
and the like. Vitamin E can be administered as a tocopherol or a mixture
of tocopherols and various derivatives thereof such as esters like
vitamin E acetate, succinate, palmitate, and the like. The alpha form is
preferable but beta, gamma and delta forms can be included. The d form is
preferable but racemic mixtures are acceptable. The forms and derivatives
will function in a Vitamin E like activity after ingestion by the pet.
Vitamin C can be administered in this diet as ascorbic acid and its
various derivatives thereof such as calcium phosphate salts, cholesteryl
salt, 2-monophosphate, and the like which will function in a vitamin C
like activity after ingesting by the pet. They can be in any form such as
liquid, semisolid, solid and heat stable form. L-carnitine can be
administered in the diet and various derivatives of carnitine such as the
salts such as the hydrochloride, fumarate and succinates, as well as
acetylated carnitine, and the like can be used.

[0092] As contemplated herein, functional ingredients and nutrients for
use in the present invention include walnut oil, sesame oil, sunflower
oil, capsibiol-T, pomegranate, magnolia, lipoic acid, vitamin C, ginger,
green and black tea, optionally together with an optimal fiber blend of
soluble and insoluble fibers. Juices, extracts, pulp or other forms of
formulations of said ingredients are included.

[0093] In various embodiments, the pet food composition can further
include corn, poultry meal, palatability enhancers, potassium chloride,
iodized salt, calcium carbonate, choline chloride, minerals, mineral
premix, preservatives, vitamins, and mixtures thereof. In certain
embodiments, the dietary food composition may further include
L-tryptophan. The quantities administered in the diet, all as wt % (dry
matter basis) of the diet, are calculated as the active material, per se,
that is measured as free material. The maximum amounts employed should
not bring about toxicity. At least about 100 ppm or at least about 150
ppm of Vitamin E can be used. A preferred range of 500 to 1,000 ppm can
be employed. Although not necessary, a maximum of about 2000 ppm or about
1500 ppm is generally not exceeded. With respect to Vitamin C at least
about 50 ppm is used, desirably at least about 75 ppm and more desirably
at least about 100 ppm. A non-toxic maximum can be employed. The quantity
of lipoic acid can vary from at least about 25, desirably at least about
50 ppm, more desirably about 100 ppm. Maximum quantities can vary from
100 ppm to 600 ppm or to an amount which remains non-toxic to the pet. A
preferred range is from 100 ppm to 200 ppm. For l-carnitine about 50 ppm,
desirably about 200 ppm, more desirably about 300 ppm for canines are a
useful minimum. For felines, slightly higher minimums of l-carnitine can
be employed such as about 100 ppm, 200 ppm, and 500 ppm. A non-toxic
maximum quantity can be employed, for example, less than about 5,000 ppm.
For canines, lower quantities can be employed, for example, less than
about 5,000 ppm. For canines, a preferred range is 200 ppm to 400 ppm.
For felines, a preferred range is 400 ppm to 600 ppm. Beta-carotene at
1-15 ppm can be employed. Selenium at 0.1 up to 5 ppm can be employed.
Lutein at least about 5 ppm can be employed. Tocotrienols at least about
25 ppm can be employed. Coenzyme Q10 at least about 25 ppm can be
employed. S-adenosylmethionine at least about 50 ppm can be employed.
Taurine at least about 1000 ppm can be employed. Soy isoflavones at least
about 25 ppm can be used. N-acetylcysteine at least about 50 ppm can be
used. Glutathione at least about 50 ppm can be used. Gingko Biloba at
least 50 ppm of extract can be used.

[0094] In various embodiments, the pyruvate may be added to the animal's
food. In various embodiments, the pyruvate may be added to the animal's
food by a compounder or manufacturer at a site or by an animal's
caregiver prior to feeding the animal. In various embodiments, the
pyruvate may be added during the processing of an animal's food, such as
during and/or after mixing of other components of the composition that is
then packaged and made available to consumers. Such processing may
include extrusion, canning, baking, and the like or any other method or
process of producing pet foods that is known in the art. In various
embodiments, the pyruvate may be contributed by a natural source like an
animal or plant component or the pyruvate may be contributed by a
synthetically derived source or the pyruvate may be contributed by a
mixture of natural and synthetic sources.

[0095] The edible compositions of the invention may be prepared in a
canned or wet form using conventional food preparation processes known to
skilled artisans. Typically, ground animal proteinaceous tissues are
mixed with the other ingredients such as fish oils, cereal grains,
balancing ingredients, special purpose additives (e.g., vitamin and
mineral mixtures, inorganic salts, cellulose and beet pulp, bulking
agents, and the like) and water in amounts sufficient for processing.
These ingredients are mixed in a vessel suitable for heating while
blending the components. Heating of the mixture is effected using any
suitable manner, for example, direct steam injection or using a vessel
fitted with a heat exchanger. When heated to the appropriate temperature,
the material will typically be in the form of a thick liquid. The thick
liquid is filled into cans. A lid is applied, and the container is
hermetically sealed. The sealed can is then placed into conventional
equipment designed to sterilize the contents. The compositions of the
present invention can be added to the food compositions before, during,
or after preparation.

[0096] Food compositions may be prepared in a dry form using conventional
processes known to skilled artisans. Typically, dry ingredients such as
animal protein, plant protein, grains, and the like are ground and mixed
together. Moist or liquid ingredients, including fats, oils, animal
protein, water, and the like are then added to and mixed with the dry
mix. The mixture is then processed into kibbles or similar dry pieces.
Kibble is often formed using an extrusion process in which the mixture of
dry and wet ingredients is subjected to mechanical work at a high
pressure and temperature and forced through small openings and cut off
into kibble by a rotating knife. The wet kibble is then dried and
optionally coated with one or more topical coatings such as flavours,
fats, oils, powders, and the like. Kibble also can be made from the dough
using a baking process, rather than extrusion, wherein the dough is
placed into a mold before dry-heat processing.

[0097] In preparing a composition for use with the methods of the present
invention, any ingredient (e.g., fish oil) generally may, for example, be
incorporated into the composition during the processing of the
formulation, such as during and/or after mixing of other components of
the composition. Distribution of these components into the composition
can be accomplished by conventional means. In one embodiment, ground
animal and poultry proteinaceous tissues are mixed with the other
ingredients, including fish oils, cereal grains, other nutritionally
balancing ingredients, special-purpose additives (e.g., vitamin and
mineral mixtures, inorganic salts, cellulose and beet pulp, bulking
agents, and the like); and water that is sufficient for processing is
also added.

[0098] Methods of the present invention include utilizing compositions
that can be prepared in a dry form using conventional processes. In one
embodiment, dry ingredients, including, for example, animal protein
sources, plant protein sources, grains, etc., are ground and mixed
together. Moist or liquid ingredients, including fats, oils, animal
protein sources, water, etc., are then added to and mixed with the dry
mix. The mixture is then processed into kibbles or similar dry pieces.
Kibble is often formed using an extrusion process in which the mixture of
dry and wet ingredients is subjected to mechanical work at a high
pressure and temperature, and forced through small openings and cut off
into kibble by a rotating knife. The wet kibble is then dried and
optionally coated with one or more topical coatings which may include,
for example, flavors, fats, oils, powders, and the like. Kibble also can
be made from the dough using a baking process, rather than extrusion,
wherein the dough is placed into a mold before dry-heat processing.

[0099] The compositions may also be designed to be easier to chew. Canine
and feline foods are typically formulated based on life stage (age),
size, body composition, and breed. In the methods of this invention, some
embodiments of the compositions address specific nutritional differences
between senior regular or small breed dogs, large breed dogs, and cats.

[0101] In one embodiment, the compositions are in the foam of a companion
animal food composition or pet food.

[0102] Foods of any consistency or moisture content are contemplated,
e.g., the compositions of the present invention may be a moist,
semi-moist, or dry animal food composition. "Moist" food refers to food
that has a moisture content of 60 to 90% or greater. "Dry" food refers to
compositions with 3 to 11% moisture content and is often manufactured in
the form of small bits or kibbles. "Semi-moist" refers to compositions
with 25-35% moisture content. Also contemplated herein are compositions
that may comprise components of various consistency as well as components
that may include more than one consistency, for example, soft, chewy
meat-like particles as well as kibble having an outer cereal component
and an inner cream component as described in, e.g., U.S. Pat. No.
6,517,877.

[0103] The edible composition can be a liquid or a solid food. When the
composition is a liquid, the pyruvate can be admixed with other
components. Where the composition is solid, the pyruvate may be coated on
the composition, incorporated into the composition, or both.

[0104] In certain embodiments, the edible composition can be a supplement.
Supplements include, for example, a feed used with another feed to
improve the nutritive balance or performance of the total. Supplements
include compositions that are fed undiluted as a supplement to other
feeds, offered free choice with other parts of an animal's ration that
are separately available, or diluted and mixed with an animal's regular
feed to produce a complete feed. AAFCO, for example, provides a
discussion relating to supplements in the Official Publication of The
Association of American Feed Control Officials, Inc. (2009). Supplements
may be in various forms including, for example, powders, liquids, syrups,
pills, encapsulated compositions, and the like.

[0105] In certain embodiments, the edible composition can be a treat.
Treats include compositions that are given to an animal to entice the
animal to eat during a non-meal time, for example, dog bones for canines.
Treats may be nutritional wherein the composition includes one or more
nutrients and may have a food-like composition. Non-nutritional treats
encompass any other treats that are non-toxic. The composition or
components are coated onto the treat, incorporated into the treat, or
both. Treats of the invention can be prepared by an extrusion or baking
process similar to those used for dry food. Other processes also may be
used to either coat the composition on the exterior of existing treat
forms or inject the composition into an existing treat form.

[0106] In certain embodiments, the edible composition can be a toy. Toys
include chewable toys such as artificial bones. The at least one pyruvate
can form a coating on the surface of the toy or on the surface of a
component of the toy, be incorporated partially or fully throughout the
toy, or both. In one embodiment, the one or more pyruvate is orally
accessible by the intended user. There are a wide range of suitable toys
currently marketed, for example, U.S. Pat. No. 5,339,771, U.S. Pat. No.
5,419,283, and references disclosed therein. This invention provides both
partially consumable toys, for example, toys including plastic
components, and fully consumable toys, for example, rawhides and various
artificial bones. The invention preferably provides toys for use by a dog
or a cat.

[0107] The invention also encompasses methods of preventing, ameliorating
one or more symptoms of, or treating certain disorders by administering a
therapeutically or prophylactically effective amount of a composition
including one or more pyruvate to a companion animal in need thereof.

[0108] In one embodiment the composition providing a therapeutically or
prophylactically effective amount of one or more pyruvate is administered
in a nutritionally complete dietary composition.

[0109] Another embodiment encompasses methods for maintaining or promoting
a healthy body composition, for example, loss of weight or body fat, or
increased percentage of lean muscle mass, in a companion animal, which
includes feeding the animal an edible composition including one or more
pyruvate in an amount effective to promote or maintain the healthy body
composition.

[0110] In another embodiment, the invention encompasses the use of an
edible composition including one or more pyruvate for the manufacture of
a medicament for maintaining or promoting a healthy body composition in a
companion animal. In certain embodiments, the invention encompasses
administering the composition including one or more pyruvate to
overweight or obese companion animals. The composition may also be fed to
companion animals that are healthy in order to maintain a healthy body
composition. The invention is based upon the discovery that the presence
of one or more pyruvate in an animal's diet enhances or improves weight
promotion and maintenance.

Specific Embodiments of the Invention

[0111] The invention is further described in the following examples. The
examples are merely illustrative and do not in any way limit the scope of
the invention as described and claimed. This invention can be further
illustrated by the following examples of preferred embodiments thereof,
although it will be understood that these examples are included merely
for purposes of illustration and are not intended to limit the scope of
the invention unless otherwise specifically indicated.

EXAMPLES

Example 1

Effect of Pyruvate on Body Composition in Canine and Feline Studies
Materials and Methods

[0112] 28 cats were fed a control food for 28 days prior to the start of
the study. At day 0, cats were allotted to one of two foods, the control
food or the control food+pyruvate. Cats were fed the experimental foods
for 45 days. At day 0 and 45, blood was harvested to determine chemistry
profile and Dual energy x-ray absorptiometry (DEXA) was performed to
determine changes in body composition.

[0113] 40 dogs were fed a control food for 28 days prior to start of the
study. At day 0, dogs were allotted to one of three experimental foods,
control+fish oil, control+pyruvate, or control+fish oil and pyruvate.
Dogs were fed the experimental foods for 45 days. At day 0 and 45, blood
was harvested to determine chemistry profile and DEXA was performed to
determine changes in body composition.